LAP-BAND(R) System Weight-Loss Surgery Associated With More Than 70 Percent Reduced Risk of Death in People With Severe Obesity

... Observational study published in the Annals of Surgery ...MELBOURNE Australia Nov. 21 /- Severely obese people wh... This research is critical because it shows that people with severeob...The study involved two groups of people who were between 37 and 70yea...

MELBOURNE, Australia, Nov. 21 /PRNewswire/ -- Severely obese people who
received the LAP-BAND(R) Adjustable Gastric Banding System to lose weight
had a 72 percent reduction in their risk of dying compared to obese people
who were not offered any specific weight-loss treatment, according to
findings published in the December issue of the Annals of Surgery (1). The
LAP-BAND(R) System was approved in June 2001 by the U.S. Food & Drug
Administration for weight reduction in severely obese adults.

"This research is critical because it shows that people with severe
obesity, who are known to be at a much higher risk than the general
population for dying prematurely, may be able to significantly decrease
their risk with laparoscopic adjustable gastric banding," explains Dr. Paul
O'Brien, FRACS a study author from the Monash University Centre for Obesity
Research and Education (CORE) in Melbourne, Australia, head of the Centre
for Bariatric Surgery in Melbourne and the National Medical Director for
the American Institute of Gastric Banding in Dallas, Texas. "What is also
particularly compelling is that this study shows it is possible to gain a
significant survival benefit without the risks associated with more
invasive bariatric surgical procedures, such as gastric bypass."

The study involved two groups of people who were between 37 and 70
years of age with a Body Mass Index (BMI) of 35 kg/m2 or greater: A
LAP-BAND(R) System group, which included 966 patients (average age 47,
average BMI 45 kg/m2) and a previously established population-based cohort
of 2119 people who were not offered any specific weight-loss treatment
(average age 55, average BMI 38 kg/m2). There were four deaths (heart
disease, cancer(2) and suicide) in the LAP-BAND(R) System group after a
median follow-up of four years, vs. 225 deaths after a median follow-up of
12 years in the non-treated group. After statistically controlling for the
differences in follow up time, sex, age and BMI, the hazard for death was
72 percent lower for LAP-BAND(R) System patients compared to the
non-treated group (hazard ratio for death: 0.28, 95% confidence interval:
0.10-0.85). LAP-BAND(R) System patients lost an average of approximately 63
pounds 2 years after installation.

The very low death rate seen in the LAP-BAND(R) System group, while
good news, limited the study, making it difficult to precisely determine
the magnitude of the effect of the procedure on improved survival. Also,
there may have been unknown differences between the two groups that may
have affected results. The new findings are consistent with those from
other studies showing a reduced risk of death (~30% to 89%) associated with
the weight loss following other forms of bariatric surgery (2,3,4,5,6).

About Obesity

In the United States, obesity is considered the second leading cause of
preventable death (7). Further, research has shown that individuals with a
BMI of 35 or more have a reduced life expectancy of nine to 13 years (8). A
BMI of 35 or more translates to a weight of 200 pounds or more for a woman
of average height (5' 4") when ideal weight at this height is considered to
be 140 pounds, and to a weight of 250 pounds or more for man who is six
feet tall when ideal weight for this height is considered to be 177 pounds.

About the LAP-BAND(R) System

The LAP-BAND(R) System was approved by the FDA in June 2001 for
severely obese adults with a Body Mass Index (BMI) of 40 or more or for
adults with a BMI of at least 35 plus at least one severe obesity-related
health condition, such as Type 2 diabetes, hypertension and asthma. Used in
more than 300,000 procedures worldwide, this simple reversible surgically
implanted device has safely helped severely obese adults successfully
achieve and maintain long- term weight loss.

The LAP-BAND(R) System was developed to facilitate long-term weight
loss and reduce the health risks associated with severe and morbid obesity.
Unlike gastric bypass, it does not involve stomach cutting, stapling or
intestinal re-routing (9,10). Using laparoscopic surgical techniques, the
device is placed around the top portion of the patient's stomach, creating
a small pouch. By reducing stomach capacity, the LAP-BAND(R) System can
help achieve long-term weight loss by creating an earlier feeling of
satiety. The LAP-BAND(R) System is adjustable, which means that the
inflatable band can be tightened or loosened to help the patient achieve a
level of satiety while maintaining a healthy diet. It is also reversible
and can be removed at any time.

About CORE at Monash University

CORE is a Monash University centre that operates within the Faculty of
Medicine, Nursing and Health Sciences. The mission of CORE is to understand
the disease of obesity, to identify optimal methods for its long-term
management that are safe and cost effective, and to determine preventive
strategies that can be implemented.

Dr. Paul O'Brien is one of the world's leading experts in laparoscopic
adjustable gastric banding, using the LAP-BAND(R) System. He is Head of the
Centre for Bariatric Surgery in Melbourne, National Medical Director for
the American Institute of Gastric Banding in Dallas, Texas, and is Emeritus
Professor of Surgery and Head of the Centre for Obesity Research and
Education (CORE) at Monash University in Melbourne.

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